Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance
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|ClinicalTrials.gov Identifier: NCT03024476|
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : April 6, 2018
BOSS-Trial I is a phase 2 clinical trial with the following objectives;
- to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server;
- to prove the feasibility of the BP management strategy, including the pre-specified BP range, BP management algorithm, and behavioral; and
- to gather information for the phase 3 trial including BP variability indices and their potentials as a treatment guidance.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Hypertension||Behavioral: Behavioral intensification Drug: Pharmacological intensification based on olmesartan Device: Bluetooth-equipped sphygmomanometer||Phase 2|
- Elevated blood pressure is an established risk factor for recurrent stroke and vascular events in ischemic stroke survivors, but
Current guideline (JNC VIII) has omitted or only partially covered a number of practical and important issues as follow;
- When and how we measure blood pressure?
- Is it justifiable to apply the same blood pressure threshold for office BP and home BP?
- Should stroke survivors be treated by the same BP goal for non-stroke subjects?
- Is it justifiable to apply the universal BP threshold for different mechanisms of ischemic stroke?
- Is it really about only blood pressure or might it really be "beyond blood pressure?"
- Lifestyle modification should accompany all the pharmacological intervention but is usually in adequate to initiate behavioral changes.
- Frequent BP measurement at home will provide more detailed and reliable information than occasional office BP's.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||December 7, 2017|
|Actual Study Completion Date :||December 7, 2017|
Experimental: Intensive management arm
Behavioral: Behavioral intensification
Suggested algorithm for behavioral intensification:
Drug: Pharmacological intensification based on olmesartan
Device: Bluetooth-equipped sphygmomanometer
Active Comparator: Control arm
Device: Bluetooth-equipped sphygmomanometer
- Recruitment time to prespecified number of subjects [ Time Frame: At 3 months after randomization ]Difference in days between recruitment of the first subject and last subject
- Retention of included participants [ Time Frame: At 3 months after randomization ]Ratio of completed subject over randomized subjects in each group
- Frequencies of calls for breakthrough visit [ Time Frame: At 3 months after randomization ]Mean and standard deviation of breakthrough visits per each patient in the intensive management group
- Rate of patients who responded to the calls for breakthrough visit [ Time Frame: At 3 months after randomization ]ratio of subjects response over the breakthrough visit calls
- Control of blood pressure [ Time Frame: At 3 months after randomization ]ratio of subjects with well-controlled BP in each group
- Frequency of out-of-range measurement [ Time Frame: At 3 months after randomization ]Frequency of BP measurements out of the desirable BP range in a week
- Weighted hit score of BP [ Time Frame: At 3 months after randomization ]When two consecutive hits crossed over or below the margin of desirable BP, give 2x weight. Final score will be generated by dividing by total number of measurements
- Vascular events [ Time Frame: At 3 months after randomization ]Recurrent vascular events including recurrent stroke, myocardial infarction or vascular death
- Hypotensive events [ Time Frame: Until 3 months after randomization ]Complaint of dizzy spells, falls or low-BP related events by patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024476
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi, Korea, Republic of, 13520|
|Nowon Eulji Medical Center, Eulji University|
|Seoul, Korea, Republic of, 01830|
|Seoul Medical Center|
|Seoul, Korea, Republic of, 02053|
|Principal Investigator:||Hee-Joon Bae, MD.PhD||Seoul National University Bundang Hospital|